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| Skip to content enquiry@operonstrategist.com * Home * About Us * Services Menu Toggle + Turnkey Project Consultants Menu Toggle o Medical Device Quality Management System Menu Toggle - FDA 21 CFR Part 820 Quality System Regulation - ISO 13485 – QMS Medical Device - QMS Software (eQMS) - ISO 15378:2017 Certification | Primary Packaging Regulatory Consulting - MDSAP o Product Feasibility & Detail Project Report o Manufacturing Facility o Validation Documentation o Clean Room Guidance + Regulatory Approvals Menu Toggle o US FDA 510(k) Consultant o CDSCO Registration Menu Toggle - CDSCO Import License - CDSCO Manufacturing License o CE Mark for Medical Device o UKCA Regulatory Consultant o Russia Medical Device Registration o SFDA Approvals + Medical Device Design & Development Documentation Menu Toggle o Drug Device Combination Products o Design History File o US FDA 21 CFR 820.30 Design Controls Requirements * Testimonials * Blog * Newsletter * Contact Us Search for: Search Search Main Menu * Home * About Us * Services Menu Toggle + Turnkey Project Consultants Menu Toggle o Medical Device Quality Management System Menu Toggle - FDA 21 CFR Part 820 Quality System Regulation - ISO 13485 – QMS Medical Device - QMS Software (eQMS) - ISO 15378:2017 Certification | Primary Packaging Regulatory Consulting - MDSAP o Product Feasibility & Detail Project Report o Manufacturing Facility o Validation Documentation o Clean Room Guidance + Regulatory Approvals Menu Toggle o US FDA 510(k) Consultant o CDSCO Registration Menu Toggle - CDSCO Import License - CDSCO Manufacturing License o CE Mark for Medical Device o UKCA Regulatory Consultant o Russia Medical Device Registration o SFDA Approvals + Medical Device Design & Development Documentation Menu Toggle o Drug Device Combination Products o Design History File o US FDA 21 CFR 820.30 Design Controls Requirements * Testimonials * Blog * Newsletter * Contact Us * Home * Blog Understanding the Regulatory Difference Between SiMD and SaMD […] Understanding the Regulatory Difference Between SiMD and SaMD Read More » What FDA investigators will look for under QMSR What FDA investigators will look for under QMSR Read More » Medical Device Documentation Gaps that Trigger Audit Findings Medical Device Documentation Gaps that Trigger Audit Findings Read More » MDSAP Audit Checklist: How to Prepare for a Successful Audit MDSAP Audit Checklist: How to Prepare for a Successful Audit Read More » Transfer CE Certificate to Another Notified Body: Complete Guide for Medical Device Manufacturers Transfer CE Certificate to Another Notified Body: Complete Guide for Medical Device Manufacturers Read More » Regulatory Dispute in India Raises Questions Over Refurbished Medical Equipment Regulatory Dispute in India Raises Questions Over Refurbished Medical Equipment Read More » EU Updates MDR and IVDR to Ease Compliance and Prevent Shortages EU Updates MDR and IVDR to Ease Compliance and Prevent Shortages Read More » Sustainable Medical Device Manufacturing: Compliance Risks Most Manufacturers Overlook Sustainable Medical Device Manufacturing: Compliance Risks Most Manufacturers Overlook Read More » Top 10 Medical Device Trends in 2026 Top 10 Medical Device Trends in 2026 Read More » Expert CDSCO Medical Device Consultants in India – (Registration & Licensing) Expert CDSCO Medical Device Consultants in India – (Registration & Licensing) Read More » 1 2 … 67 Next → Load More Download Newsletter Please enable JavaScript in your browser to complete this form. Name * Email * Custom Captcha * = Download Newsletter Subscriptions Categories * CDSCO * CE Marking * Design and Development * Digital Marketing * Event * Manufacturing Site Design and Conceptualization * Medical device Manufacturing * News * News/Updates * Post Marketing Support * QMS Certification Services * Regulatory Compliance * Turnkey Project Management * Uncategorized * US FDA Recent Posts * Understanding the Regulatory Difference Between SiMD and SaMD * What FDA investigators will look for under QMSR * Medical Device Documentation Gaps that Trigger Audit Findings * MDSAP Audit Checklist: How to Prepare for a Successful Audit * Transfer CE Certificate to Another Notified Body: Complete Guide for Medical Device Manufacturers O peron Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of the medical device. Services * Regulatory Services + US FDA 510(k) Consultant + CDSCO Registration + CE Mark for Medical Device + UKCA Regulatory Consultant * Turnkey Project Consultants + Clean Room Guidance + Manufacturing Facility + Medical Device Quality Management System * More Services Useful Links * About Us * Blog * Contact Us * Testimonials * Careers * Upcoming Events and Expos * FAQ * Newsletter * Privacy Policy Office Address Address : Office 14, 4th Floor, MSR Capital, Morwadi Road, Pimpri Colony, Pimpri, Pune 411018 Mail Us: enquiry@operonstrategist.com Call Us Now: +91 87679 80322 | +91 90280 43428 | +91 93252 83428 © 2026 Operon Strategist | Powered by Operon Strategist Download our Latest Newsletter To download the newsletter. Fill the information and download our newsletter. Please enable JavaScript in your browser to complete this form. Name * Email * Custom Captcha * = Download × Scroll to Top | Skip to content enquiry@operonstrategist.com * Home * About Us * Services Menu Toggle + Turnkey Project Consultants Menu Toggle o Medical Device Quality Management System Menu Toggle - FDA 21 CFR Part 820 Quality System Regulation - ISO 13485 – QMS Medical Device - QMS Software (eQMS) - ISO 15378:2017 Certification | Primary Packaging Regulatory Consulting - MDSAP o Product Feasibility & Detail Project Report o Manufacturing Facility o Validation Documentation o Clean Room Guidance + Regulatory Approvals Menu Toggle o US FDA 510(k) Consultant o CDSCO Registration Menu Toggle - CDSCO Import License - CDSCO Manufacturing License o CE Mark for Medical Device o UKCA Regulatory Consultant o Russia Medical Device Registration o SFDA Approvals + Medical Device Design & Development Documentation Menu Toggle o Drug Device Combination Products o Design History File o US FDA 21 CFR 820.30 Design Controls Requirements * Testimonials * Blog * Newsletter * Contact Us Search for: Search Search Main Menu * Home * About Us * Services Menu Toggle + Turnkey Project Consultants Menu Toggle o Medical Device Quality Management System Menu Toggle - FDA 21 CFR Part 820 Quality System Regulation - ISO 13485 – QMS Medical Device - QMS Software (eQMS) - ISO 15378:2017 Certification | Primary Packaging Regulatory Consulting - MDSAP o Product Feasibility & Detail Project Report o Manufacturing Facility o Validation Documentation o Clean Room Guidance + Regulatory Approvals Menu Toggle o US FDA 510(k) Consultant o CDSCO Registration Menu Toggle - CDSCO Import License - CDSCO Manufacturing License o CE Mark for Medical Device o UKCA Regulatory Consultant o Russia Medical Device Registration o SFDA Approvals + Medical Device Design & Development Documentation Menu Toggle o Drug Device Combination Products o Design History File o US FDA 21 CFR 820.30 Design Controls Requirements * Testimonials * Blog * Newsletter * Contact Us * Home * Blog EU MDR Common Pitfalls That Delay Medical Device Approval in Europe […] EU MDR Common Pitfalls That Delay Medical Device Approval in Europe Read More » Understanding the Regulatory Difference Between SiMD and SaMD Understanding the Regulatory Difference Between SiMD and SaMD Read More » What FDA investigators will look for under QMSR What FDA investigators will look for under QMSR Read More » Medical Device Documentation Gaps that Trigger Audit Findings Medical Device Documentation Gaps that Trigger Audit Findings Read More » MDSAP Audit Checklist: How to Prepare for a Successful Audit MDSAP Audit Checklist: How to Prepare for a Successful Audit Read More » Transfer CE Certificate to Another Notified Body: Complete Guide for Medical Device Manufacturers Transfer CE Certificate to Another Notified Body: Complete Guide for Medical Device Manufacturers Read More » Regulatory Dispute in India Raises Questions Over Refurbished Medical Equipment Regulatory Dispute in India Raises Questions Over Refurbished Medical Equipment Read More » EU Updates MDR and IVDR to Ease Compliance and Prevent Shortages EU Updates MDR and IVDR to Ease Compliance and Prevent Shortages Read More » Sustainable Medical Device Manufacturing: Compliance Risks Most Manufacturers Overlook Sustainable Medical Device Manufacturing: Compliance Risks Most Manufacturers Overlook Read More » Top 10 Medical Device Trends in 2026 Top 10 Medical Device Trends in 2026 Read More » 1 2 … 67 Next → Load More Download Newsletter Please enable JavaScript in your browser to complete this form. Name * Email * Custom Captcha * = Download Newsletter Subscriptions Categories * CDSCO * CE Marking * Design and Development * Digital Marketing * Event * Manufacturing Site Design and Conceptualization * Medical device Manufacturing * News * News/Updates * Post Marketing Support * QMS Certification Services * Regulatory Compliance * Turnkey Project Management * Uncategorized * US FDA Recent Posts * EU MDR Common Pitfalls That Delay Medical Device Approval in Europe * Understanding the Regulatory Difference Between SiMD and SaMD * What FDA investigators will look for under QMSR * Medical Device Documentation Gaps that Trigger Audit Findings * MDSAP Audit Checklist: How to Prepare for a Successful Audit O peron Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of the medical device. Services * Regulatory Services + US FDA 510(k) Consultant + CDSCO Registration + CE Mark for Medical Device + UKCA Regulatory Consultant * Turnkey Project Consultants + Clean Room Guidance + Manufacturing Facility + Medical Device Quality Management System * More Services Useful Links * About Us * Blog * Contact Us * Testimonials * Careers * Upcoming Events and Expos * FAQ * Newsletter * Privacy Policy Office Address Address : Office 14, 4th Floor, MSR Capital, Morwadi Road, Pimpri Colony, Pimpri, Pune 411018 Mail Us: enquiry@operonstrategist.com Call Us Now: +91 87679 80322 | +91 90280 43428 | +91 93252 83428 © 2026 Operon Strategist | Powered by Operon Strategist Download our Latest Newsletter To download the newsletter. Fill the information and download our newsletter. Please enable JavaScript in your browser to complete this form. Name * Email * Custom Captcha * = Download × Scroll to Top |
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